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MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)

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ClinicalTrials.gov Identifier: NCT00506077
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : March 7, 2011
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Paranoid Schizophrenia
Interventions: Drug: MK0249
Drug: Comparator: Placebo (unspecified)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient Dosed: 11 February 2008; Last Patient Last Treatment: 08 October 2008. Six ex-U.S. study centers (3 Russia, 3 India).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At visit 1, patients were assessed using the protocol eligibility criteria. Eligible patients continued into an 8 day single-blind placebo washout/run-in period, and then were randomized at visit 3 to 1 of 2 cross-over treatment sequences.

Reporting Groups
  Description
MK0249 Then Placebo These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
Placebo Then MK0249 These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.

Participant Flow for 3 periods

Period 1:   Treatment Period 1
    MK0249 Then Placebo   Placebo Then MK0249
STARTED   28   27 
COMPLETED   24   24 
NOT COMPLETED   4   3 
Adverse Event                2                1 
Lost to Follow-up                0                2 
Withdrawal by Subject                2                0 

Period 2:   Washout
    MK0249 Then Placebo   Placebo Then MK0249
STARTED   24   24 
COMPLETED   24   24 
NOT COMPLETED   0   0 

Period 3:   Treatment Period 2
    MK0249 Then Placebo   Placebo Then MK0249
STARTED   24   24 
COMPLETED   23   23 
NOT COMPLETED   1   1 
Adverse Event                0                1 
Withdrawal by Subject                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MK0249 Then Placebo These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
Placebo Then MK0249 These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
Total Total of all reporting groups

Baseline Measures
   MK0249 Then Placebo   Placebo Then MK0249   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   27   55 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.7  (7.5)   32.5  (8.4)   31.6  (7.9) 
Gender 
[Units: Participants]
     
Female   8   7   15 
Male   20   20   40 


  Outcome Measures

1.  Primary:   Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.   [ Time Frame: Baseline and 4 weeks of treatment ]

2.  Secondary:   Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score   [ Time Frame: Baseline and 4 weeks of treatment ]

3.  Secondary:   Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score   [ Time Frame: Baseline and 4 weeks of treatment ]

4.  Secondary:   Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score   [ Time Frame: Baseline and 4 weeks of treatment ]

5.  Other Pre-specified:   Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.   [ Time Frame: Pre-randomization Baseline ]

6.  Other Pre-specified:   Pre-randomization Baseline: Attention/Processing Speed Composite Score   [ Time Frame: Pre-randomization Baseline ]

7.  Other Pre-specified:   Pre-randomization Baseline: Episodic Memory Composite Score   [ Time Frame: Pre-randomization Baseline ]

8.  Other Pre-specified:   Pre-randomization Baseline: Working Memory Composite Score   [ Time Frame: Pre-randomization Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information